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Par to test each batch of megestrol acetate for microbial contamination following FDA warning letter.

Executive Summary

PAR MEGESTROL ACETATE MICROBIAL TESTING ON EVERY FIFTH BATCH WAS INADEQUATE in 1996 to prevent product contamination, FDA told the company in a Jan. 10 warning letter. There was "no assurance that every batch" of Par megestrol acetate 20 mg and 40 mg tabs made during the first nine months of 1996 "met internal microbial specifications, since testing was conducted on every fifth batch produced between Feb. 8 to March 25, March 30 to May 9 and May 28 to June 15, 1996," FDA told the company.

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